Clinical QA Manager
4 weeks ago
Description
We're looking for a
Clinical QA Manager , working in
Pharmaceuticals
and
Medical Products
industry in
155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States .
Job description:
Chairs the Regulatory Authority Facilitation Team, and ensures that company clinical facility and clinical sites are prepared for clinical inspections and the inspections are successfully facilitated.
Writes Inspection Readiness Plans as necessary.
Facilitates sponsor and site inspections as necessary.
Manages the Clinical Document Audit function, and plans, prepares, performs, and reports on CQA audits of Clinical Study Reports and Trial Master Files.
Develops Study Audit Plans and prepares, performs, and reports on CQA audits of investigator sites.
Plans, prepares, performs, and reports on CQA audits of internal processes.
Provides GCP and Lessons Learned training.
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